This invention relates generally to a management system and a method of providing patient care in the home or alternate care setting, i.e., to a system which functions as a virtual hospital room.
A hospital room is a place where a patient can receive medical treatment and have his physiological condition monitored under the supervision of a healthcare professional both continuously and at prescribed times. As the cost of health care increases, the trend is to discharge the patient from the hospital earlier, but to continue the therapy at the patient""s home or at an alternative care facility. Various medical devices, such as infusion pumps and respirators, allow the patient to receive therapy outside the hospital environment. In many instances the caregiver must visit the patient""s home to monitor and control the medical device. Some medical devices, however, include means for enabling the caregiver (or healthcare professional) to monitor and control the medical device""s functions from a remote location.
Co-pending U.S. patent application Ser. No. 08/951,976, filed Oct. 16, 1997, titled xe2x80x9cMedical Apparatus With Remote Virtual Input Devicexe2x80x9d, which is assigned to the assignee of this application, describes a medical apparatus for remote monitoring and controlling of a medical treatment device, such as an infusion pump. The medical apparatus described therein includes a medical device for administering a medical treatment and a remote controller. The caregiver can control operation of the medical device either at the patient""s location using the device""s input device or from the remote location by activating a virtual input device.
U.S. Pat. No. 5,807,336 for xe2x80x9cApparatus for Monitoring and/or Controlling a Medical Devicexe2x80x9d, which is assigned to the assignee of this application, describes an apparatus for remotely monitoring and controlling a medical device in which stored data can be transferred from the medical device on a real-time basis to the remote controller while the medical device is administering medical treatment.
Co-pending U.S. patent application Ser. No. 08/703,543, filed Aug. 27, 1996, titled xe2x80x9cMedical Treatment Apparatus and Methodxe2x80x9d, which is assigned to the assignee of this application, describes a combination of a medical treatment device, such as an infusion pump, and one or more sensors, which detect the medical condition of the patient. The sensors are connected to the medical treatment device, so that signals generated by the sensors, which indicate the patient""s medical condition, can be stored as data in a memory contained within the medical treatment device. By connecting the sensors directly to the medical treatment device, such data can be safely stored within the device for later downloading by a remote monitor/controller. The use of such sensors during the administration of a treatment, however, may limit the patient""s mobility.
U.S. Pat. No. 5,522,396 to Langer et al. discloses a remote system for monitoring a patient""s heart. A patient station, which is intended to be worn by the patient, includes a monitor for monitoring a patient""s heart or other physiological function and a transmitter for transmitting data. The patient station, however, does not provide for alarms should the patient""s condition require contacting the caregiver.
U.S. Pat. No. 5,590,648 to Mitchell et al. discloses a unitary command center (generally resembling a cart) having a computer for receiving, storing, processing and transmitting information, and a plurality of interfacing ports. Various patient monitoring sensors modules and therapy modules are intended to be connected to the ports. However, the command center is suitable for an ambulatory patient.
U.S. Pat. No. 5,678,562 to Sellers discloses an ambulatory physiological monitor intended for Holter monitoring with a removable disk cartridge and a wireless modem. Transmitting data over a cell phone system is costly and not all patients may be capable of using the removable disk cartridges.
U.S. Pat. No. 5,568,814 to Gallant et al. discloses an ambulatory patient monitoring system for measuring and storing predetermined diagnostic parameters of a patient. One or more plug-in sensor units is coupled to a portable portion of the system, which is worn by the patient. The portable portion is designed to be coupled to a personal computer for programming, downloading and monitoring of the data, but does not provide for alarms should the patient""s condition be outside prescribed values.
In addition to providing therapy at home or in the alternative care facility, many patients may still need monitoring of their physiological conditions. Some patients may require continuous monitoring of respiration and heart rate, for example. Other patients may only need their vital signs, such as temperature, blood pressure, heart rate, taken at scheduled times or when a caregiver requests the measurements, such as for diagnosis.
There is a need for a patient home management system which provides for continuous monitoring of physiological conditions of an ambulatory patient. There is a need for a lightweight, easy to wear patient monitor for an ambulatory patient, which can be configured to accept a wide variety of diagnostic and monitoring sensors. There is a need for an ambulatory patient monitor which is versatile, but not unnecessarily complex. There is a need for a patient home management system which provides for measurement of a patient""s vital signs on a regular schedule or at the direction of a caregiver at a remote location. There is a need for a patient home management system which provides for ease of communication with the caregiver. There is a need for a patient home management system which provides for the storage and transmission of patient physiological condition data. There is also a need for a patient home management system which monitors the patient""s condition and when the patient""s physiological condition falls outside prescribed limits, provides a means of notifying the patient to contact the caregiver or automatically contacts the caregiver. There is a further need for a patient home management system which provides for the monitoring of the various sensors used to detect the patient""s physiological condition.
A patient home management system embodying the invention provides a comprehensive system for monitoring ambulatory or homebound patients in the home or alternative care environment. The patient management system includes a programmable, ambulatory patient monitor for monitoring and recording a plurality of physiological conditions of a patient. A plurality of patient monitoring sensors are electrically coupled to the programmable, ambulatory patient monitor. Each sensor detects a particular physiological condition of the patient, such as core temperature, respiration characteristics including respiration rate, electrocardiographic electrodes for providing signals to produce an electrocardiogram and blood oximetry sensors. The ambulatory patient monitor is small and compact and easily worn by the patient during his normal at-home activities.
To provide communication with the caregiver, a communications unit is disposed in the patient""s home or the alternate care facility. The communications unit includes a modem or other telecommunications device which can communicate with a remote controller at the caregiver""s office. The communications unit is generally larger than the ambulatory patient monitor and is situated at a convenient location where the patient can hear or see messages from it. The communications unit may be selectively coupled to the programmable, ambulatory patient monitor for receiving, storing and transmitting to the remote controller patient physiological condition data and for transmitting instructions from the remote controller to the programmable, ambulatory patient monitor. The patient can communicate with the caregiver using the communications unit. When the patient connects the ambulatory patient monitor to the communications unit, the patient can communicate with the caregiver at the remote location while the caregiver is viewing patient stored data transmitted from the ambulatory patient monitor via the communications unit.
The communications unit may also be used to monitor physiological conditions of the patient which do not require continuous monitoring. For example, the communications unit may connect to and receive physiological signals from a spirometer, a blood gas analyzer, a non-invasive blood pressure monitor, a scale for measuring a patient""s weight and a temperature sensor.
The programmable, ambulatory patient monitor includes a plurality of sensor interface circuits. Each interface circuit is coupled to a particular patient monitoring sensor. Each sensor generates a physiological signal representative of a physiological condition of the patient. The interface circuit converts the physiological signal to physiological data, which is stored in memory. When the ambulatory patient monitor is connected to the communications unit, physiological data may be downloaded to the communications unit for later transmission to the remote controller. The communications unit also transmits instructions from the remote controller to the ambulatory patient monitor. Such instructions include, for example, prescribed normal ranges for physiological condition readings and schedules for making particular physiological measurements.
The ambulatory patient monitor includes a processor which executes a monitoring routine in accordance with the instructions received from the remote controller. The monitoring routine compares the physiological conditions detected by the sensor with a stored instruction having a predetermined range of values for that particular sensor. If the detected signal is outside the predetermined range, a patient alarm signal is generated.
An alarm signal is generated when a sensor signal indicates a condition requiring intervention of the caregiver. When an alarm signal is generated, the patient must contact the caregiver. In doing so, the patient may call the caregiver directly or connect the ambulatory patient monitor to the communications unit. The communications unit will then automatically communicate with the remote controller. Alternatively, the communications unit may automatically contact the caregiver upon receipt of the alarm signal. Preferably the communications unit includes voice-over-data communications capability so that the patient can speak with the caregiver while the caregiver is viewing the physiological data transmitted from the communications unit to the remote controller. The alarm signal is resettable only upon receipt of a new instruction from the remote controller. This ensures that the patient contacts the caregiver when an alarm condition is detected.
The communications unit includes apparatus for communicating with the remote controller. The apparatus for communicating with the remote controller may be a typical telephone modem or voice-over-data modem, a cable modem or some form of wireless communication such as radio frequency (RF), infrared (IR) or the like. The communications unit also includes a routine for transmitting instructions received by the programmable, ambulatory patient monitor from the remote controller and for transmitting patient physiological condition data from the programmable, ambulatory patient monitor to the remote controller.
Long-term or continuous monitoring sensors are preferably connected to the ambulatory patient monitor; short-term or single measurement sensors are preferably selectively coupled to the communications unit. Examples of sensors which may be connected to the ambulatory patient monitor include sensors such as core temperature and ECG. Sensors which measure a patient""s vital signs on an infrequent or scheduled basis, such as blood pressure or weight, are preferably selectively connected to the communications unit. Additional sensors for infrequent or scheduled measurements include a spirometer, a blood gas analyzer, a non-invasive blood pressure monitor and a temperature sensor. For example, if the patient""s blood pressure must be taken twice a day, the communications unit will provide a signal to the patient to connect the blood pressure unit and take the measurement at the scheduled times. If the caregiver prefers the patient to take a particular measurement at an unscheduled time, the remote controller can communicate directly with the communications unit, which will provide a signal to the patient to take the measurement.
Signals from the communications unit and the ambulatory patient monitor can be visual or aural. Preferably, the communications unit includes a display for providing text or graphical messages to the patient and a speaker for providing spoken messages to the patient. Tones may also be used in connection with alarm signals. Preferably, the ambulatory patient monitor includes a display for graphical or textual messages, lamps for use in signalling of alarm conditions and a speaker for audio messages and tones. Additionally, a printer or other output device may be connected to the communications unit for displaying or printing out the stored data, either automatically or on demand.
Another function of both the ambulatory patient monitor and the communications unit is to monitor the operation of the sensors when measuring physiological conditions of the patient. If a sensor is attached improperly, an alert signal is provided. The patient can reset an alert signal, for example, by attaching the sensor properly in a timely fashion. Alert signals are generally not life-threatening and do not require contacting the caregiver, so they may be reset by the patient. However, if the alert signal is not reset within a reasonable time, the monitoring routine may issue an alarm signal.
The remote controller, located at a hospital or a caregiver""s office, includes software which interacts with the communications unit via the communications apparatus (i.e., by modem and a telephone line, or by another means of communication, such as wireless or cable). The remote controller software collects data stored in the communications unit and presents the information for review by the caregiver. When connected to the communications unit, the remote controller software can also program the ambulatory patient monitor by sending it new instructions and monitor the functions of the sensors connected to the ambulatory patient monitor and to the communications unit. The remote controller software can also schedule and program (i.e., set the schedule for taking measurements and for turning them on and off) the sensors connected to the ambulatory, patient monitor and the sensors selectively connected to the communications unit.